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Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) disorders in the United States. The company's product pipeline includes AXS-05, a therapeutic for the treatment of major depressive disorder and resistant depression disorders; and that is in the Phase III clinical trial to treat Alzheimer's disease agitation, as well as that has completed phase II clinical trial for the treatment of smoking cessation. It is also developing AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine that has completed two Phase III trials for the acute treatment of migraine; AXS-12, a selective and potent norepinephrine reuptake inhibitor, which is in Phase III trial to treat narcolepsy; and AXS-14, a novel, oral, and investigational medicine that is in Phase III trial for the treatment of fibromyalgia. Axsome Therapeutics, Inc. has a research collaboration agreement with Duke University for evaluating AXS-05 in smoking cessation. The company was incorporated in 2012 and is based in New York, New York.

Axsome Therapeutics, Inc.

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TOTAL 2Q 2025 NET PRODUCT REVENUE OF $150.0 MILLION, REPRESENTING GROWTH OF 72% YEAR-OVER-YEAR AND 24% SEQUENTIALLY AUVELITY  2Q 2025 NET PRODUCT SALES OF $119.6 MILLION, REPRESENTING GROWTH OF 84% YEAR-OVER-YEAR AND 24% SEQUENTIALLY SUNOSI  2Q 2025 NET PRODUCT REVENUE OF $30.0 MILLION, REPRESENTING GROWTH OF 35% YEAR-OVER-YEAR AND 19% SEQUENTIALLY SYMBRAVO  LAUNCHED JUNE 10 TH , WITH 2Q 2025 NET PRODUCT SALES OF $0.4 MILLION AUVELITY  MARKET ACCESS EXPANDED BY 28 MILLION NEW COVERED LIVES IN THE COMMERCIAL CHANNEL FIRST GROUP PURCHASING ORGANIZATION (GPO) CONTRACT FOR SYMBRAVO  SIGNED SUPPLEMENTAL NDA SUBMISSION FOR AXS-05 IN ALZHEIMER'S DISEASE AGITATION ON TRACK FOR 3Q 2025 NDA SUBMISSION FOR AXS-12 FOR CATAPLEXY IN PATIENTS WITH NARCOLEPSY ANTICIPATED IN 4Q 2025 COMPANY TO HOST CONFERENCE CALL TODAY AT 8:00 AM EASTERN NEW YORK, AUG. 04, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED FINANCIAL RESULTS FOR THE SECOND QUARTER OF 2025 AND PROVIDED A GENERAL BUSINESS UPDATE. AXSOME DELIVERED ROBUST SECOND QUARTER PERFORMANCE, REFLECTING STRONG UNDERLYING DEMAND FOR OUR LIFE-CHANGING MEDICINES, EXACTING COMMERCIAL EXECUTION, SOLID REGULATORY PROGRESS, AND CONTINUED ADVANCEMENT OF OUR DIFFERENTIATED NEUROSCIENCE PIPELINE.

AXSOME THERAPEUTICS REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

COMPREHENSIVE REVIEW OF BROAD PIPELINE TARGETING ALZHEIMER'S DISEASE AGITATION, DEPRESSION, NARCOLEPSY, FIBROMYALGIA, ADHD, AND SMOKING CESSATION, WITH NEW DATA ANALYSES

AXSOME THERAPEUTICS HOSTS FRONTIERS IN BRAIN HEALTH R&D DAY REVIEWING INDUSTRY-LEADING LATE-STAGE CNS PIPELINE

NEW YORK, JULY 09, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED IT WILL REPORT ITS FINANCIAL RESULTS FOR THE SECOND QUARTER OF 2025 ON MONDAY, AUGUST 4, 2025, BEFORE THE OPENING OF THE U.S. FINANCIAL MARKETS. AXSOME MANAGEMENT WILL THEN HOST A CONFERENCE CALL AT 8:00 A.M. EASTERN TIME TO DISCUSS THESE RESULTS AND PROVIDE A BUSINESS UPDATE.

AXSOME THERAPEUTICS TO REPORT SECOND QUARTER 2025 FINANCIAL RESULTS ON AUGUST 4

NEW YORK, JULY 07, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT WILL HOST ITS FRONTIERS IN BRAIN HEALTH R&D DAY ONJULY 21, 2025,STARTING AT 11:00 A.M. EASTERN TIME IN NEW YORK CITY. THE EVENT WILL HIGHLIGHT AXSOME'S SINGULAR, INNOVATIVE LATE-STAGE CNS PIPELINE.

AXSOME THERAPEUTICS TO SHOWCASE ITS INNOVATIVE CNS PIPELINE AT UPCOMING FRONTIERS IN BRAIN HEALTH R&D DAY IN NEW YORK CITY ON JULY 21

NEW YORK, JUNE 20, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY IS JOINING WITH THE ALZHEIMER'S DISEASE ADVOCACY COMMUNITY TO RAISE AWARENESS OF THE GROWING IMPACT OF ALZHEIMER'S DISEASE IN THE UNITED STATES AND THE IMPORTANCE OF BRAIN HEALTH DURING THIS YEAR'S ALZHEIMER'S & BRAIN AWARENESS MONTH.

AXSOME THERAPEUTICS CHAMPIONS BRAIN HEALTH DURING ALZHEIMER'S & BRAIN AWARENESS MONTH

NEW YORK, JUNE 11, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED SEVEN PRESENTATIONS, INCLUDING TWO FEATURED ORAL PLENARY SESSIONS, ON AXS-12 AND SOLRIAMFETOL, AT SLEEP 2025, THE 39TH ANNUAL MEETING OF THEASSOCIATED PROFESSIONAL SLEEP SOCIETIES (APSS), BEING HELDJUNE 8-11, 2025, INSEATTLE, WASHINGTON.

AXSOME THERAPEUTICS SHOWCASES INNOVATION IN SLEEP MEDICINE WITH MULTIPLE PRESENTATIONS FOR AXS-12 AND SOLRIAMFETOL AT SLEEP 2025

NEW YORK, MAY 29, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT WILL PARTICIPATE IN THREE UPCOMING INVESTOR CONFERENCES IN JUNE:

AXSOME THERAPEUTICS TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES

NEW YORK, MAY 27, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM) (AXSOME), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT HAS ENTERED INTO A SETTLEMENT AGREEMENT WITH HETERO LABS LTD. AND CERTAIN OF ITS AFFILIATES (HETERO) RESOLVING PATENT LITIGATION RELATED TO AXSOME'S PRODUCT SUNOSI (SOLRIAMFETOL). THE LITIGATION, WHICH IS PENDING IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY, RESULTED FROM SUBMISSION BY HETERO OF AN ABBREVIATED NEW DRUG APPLICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION SEEKING APPROVAL TO MARKET A GENERIC VERSION OF SUNOSI IN THE UNITED STATES. UNDER THE TERMS OF THE SETTLEMENT AGREEMENT, AXSOME WILL GRANT HETERO A LICENSE TO SELL ITS GENERIC VERSION OF SUNOSI BEGINNING ON OR AFTER SEPTEMBER 1, 2040, IF PEDIATRIC EXCLUSIVITY IS GRANTED FOR SUNOSI, OR ON OR AFTER MARCH 1, 2040, IF NO PEDIATRIC EXCLUSIVITY IS GRANTED, SUBJECT TO FDA APPROVAL AND CONDITIONS AND EXCEPTIONS CUSTOMARY FOR AGREEMENTS OF THIS TYPE.

AXSOME THERAPEUTICS SETTLES SUNOSI (SOLRIAMFETOL) PATENT LITIGATION WITH HETERO LABS LTD.

PREVIOUS TERM LOAN FACILITY RETIRED NEW YORK, MAY 13, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED THAT IT HAS ENTERED INTO A $570 MILLION TERM LOAN AND REVOLVING CREDIT FACILITY WITH FUNDS MANAGED BY BLACKSTONE LIFE SCIENCES AND BLACKSTONE CREDIT & INSURANCE (BLACKSTONE). CONCURRENT WITH THIS NEW FACILITY, AXSOME HAS RETIRED ITS PREVIOUS TERM LOAN WITH HERCULES CAPITAL.

AXSOME THERAPEUTICS ENTERS $570 MILLION TERM LOAN AND REVOLVING CREDIT FACILITY WITH BLACKSTONE

TOTAL 1Q 2025 NET PRODUCT REVENUE OF $121.5 MILLION, REPRESENTING 62% YEAR-OVER-YEAR GROWTH AUVELITY  1Q 2025 NET PRODUCT SALES OF $96.2 MILLION, REPRESENTING 80% YEAR-OVER-YEAR GROWTH SUNOSI  1Q 2025 NET PRODUCT REVENUE OF $25.2 MILLION, REPRESENTING 17% YEAR-OVER-YEAR GROWTH SYMBRAVO  APPROVED FOR THE ACUTE TREATMENT OF MIGRAINE; COMMERCIAL LAUNCH ON TRACK FOR JUNE 2025 NDA FOR AXS-14 FOR THE MANAGEMENT OF FIBROMYALGIA SUBMITTED TO THE FDA SUPPLEMENTAL NDA SUBMISSION FOR AXS-05 IN ALZHEIMER'S DISEASE AGITATION ON TRACK FOR 3Q 2025 NDA SUBMISSION FOR AXS-12 FOR CATAPLEXY IN PATIENTS WITH NARCOLEPSY ANTICIPATED IN 2H 2025 POSITIVE TOPLINE RESULTS OF FOCUS PHASE 3 TRIAL OF SOLRIAMFETOL IN ADHD ANNOUNCED INITIATION OF PHASE 3 TRIAL OF SOLRIAMFETOL IN MAJOR DEPRESSIVE DISORDER WITH EXCESSIVE DAYTIME SLEEPINESS ANTICIPATED IN 2025 POSITIVE TOPLINE RESULTS OF EMERGE PHASE 3 TRIAL OF SYMBRAVO IN MIGRAINE PATIENTS WITH PRIOR INADEQUATE RESPONSE TO ORAL CGRP INHIBITORS ANNOUNCED COMPANY TO HOST CONFERENCE CALL TODAY AT 8:00 AM EASTERN NEW YORK, MAY 05, 2025 (GLOBE NEWSWIRE) -- AXSOME THERAPEUTICS, INC. (NASDAQ: AXSM), A BIOPHARMACEUTICAL COMPANY LEADING A NEW ERA IN THE TREATMENT OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS, TODAY ANNOUNCED FINANCIAL RESULTS FOR THE FIRST QUARTER OF 2025 AND PROVIDED A GENERAL BUSINESS UPDATE. THE FIRST QUARTER WAS STRONG AND EVENTFUL, WITH THE APPROVAL OF SYMBRAVO FOR THE ACUTE TREATMENT OF MIGRAINE, CONTINUED GROWTH OF AUVELITY AND SUNOSI, AND SIGNIFICANT ADVANCEMENTS ACROSS OUR BROAD LATE-STAGE NEUROSCIENCE PIPELINE, SAID HERRIOT TABUTEAU, MD, CHIEF EXECUTIVE OFFICER OF AXSOME THERAPEUTICS.

Axsome Therapeutics, Inc.

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